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510(k) Data Aggregation

    K Number
    K243045
    Device Name
    “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
    Manufacturer
    BRAXX Biotech Co. Ltd
    Date Cleared
    2024-11-19

    (53 days)

    Product Code
    JAQ, JAO
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAXX Biotech Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.
    Device Description
    [BKMI2001] The device has 6 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #6 valve corresponds with the proximal balloon. There is an indication balloon on each valve unit, which can indicate the inflated balloon. The distance between first marker printed on the main catheter and the distal tip is 19.8 cm. This device is disposable and designed for sterile and single use. [BKMI2002] The device has 8 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #8 valve corresponds with the proximal balloon. The distance between first marker printed on the main catheter and the distal tip is 40 cm. This device is disposable and designed for sterile and single use.
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    K Number
    K183332
    Device Name
    “BRAXX” Esophageal Brachytherapy Applicator
    Manufacturer
    BRAXX Biotech Co. Ltd
    Date Cleared
    2019-04-16

    (134 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAXX Biotech Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use. For prescription use only
    Device Description
    A main catheter with inflatable balloons
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